SANOFI-AVENTIS U.S. LLC v. NOVO NORDISK, INC.

Full title: SANOFI-AVENTIS U.S. LLC, Plaintiff, v. NOVO NORDISK, INC., Defendant

Court: United States District Court, D. New Jersey

Date published: Jun 23, 2006

CIVIL ACTION NO. 06-1369 (MLC) (D.N.J. Jun. 23, 2006)

Opinion

CIVIL ACTION NO. 06-1369 (MLC).

June 23, 2006

MEMORANDUM OPINION

MARY COOPER, District Judge

Plaintiff, Sanofi-Aventis U.S. LLC ("Sanofi"), moves, pursuant to Federal Rule of Civil Procedure ("Rule") 65, to preliminary enjoin the defendant, Novo Nordisk, Inc. ("Novo"), "from disseminating or causing to be disseminated any false representations as to the efficacy, mechanism of action, and side effects of Levemir and Lantus." (Compl., at 25-26.) Sanofi also seeks an order directing Novo, inter alia, to (1) "take all steps necessary to secure the return and destruction of all of the false advertising," and (2) "issue corrective advertising to dispel the impact and effect of the false claims previously disseminated." (Id. at 26.)

Sanofi markets and distributes insulin glargine, a prescription long-lasting basal insulin for treating patients with diabetes, under the brand name Lantus. (Id. at 1.) Novo markets and distributes insulin detemir, a prescription long-acting basal insulin for treating patients with diabetes, under the brand name Levemir. (Id. at 1-2.). "From 2001 until Levemir's launch . . ., Lantus was the only long-acting basal insulin on the market in the United States." (4-6-06 Declaration of Brian Blakey ("Blakey Decl."), at ¶ 13; see Compl., at ¶ 36 ("[U]ntil [the launch of Levemir], Lantus has been the only branded basal (long-lasting) insulin drug in the U.S. market. When Levemir is launched in the U.S., Levemir will be Lantus' major competitor.").)

Sanofi brought this action on March 23, 2006, alleging that Novo — in the promotional campaign for Levemir — disseminated the following four false claims: (1) Levemir is "a 24-hour basal insulin" (the "24-hour claim"); (2) Levemir is a "once-daily" insulin (the "once-daily claim"); (3) Levemir is "predictable" (the "predictability claim"); and (4) Levemir causes less weight gain (the "less weight gain claim"). (Pl. Br., at 9-12.) Sanofi claims that, inter alia, Novo violated section 43(a) of the Lanham Act because the four claims are "literally false." (Id. at 13-15.)

The Court has considered the papers submitted by the parties and heard oral argument on April 11, 2006.¹ The Court hereby issues its findings of fact and conclusions of law as required by Rule 52. The Court, for the reasons stated herein, will deny the motion.

1 At oral argument, the parties waived an evidentiary hearing on this matter. (Dkt. entry no. 16, 4-11-06 Tr., at 71.)

CHRONOLOGY OF EVENTS — FACTUAL FINDINGS

I. Diabetes — Generally

Approximately 21 million people in the United States have diabetes. (3-22-06 Declaration of John E. Timberlake ("Timberlake Decl."), at ¶ 7 Ex. A; 4-6-06 Declaration of Alan C. Moses, M.D. ("Moses Decl."), at ¶ 11.) Diabetes is a "chronic disorder" that "compromises the body's production and use of insulin." (3-22-06 Declaration of John E., M.D. ("Gerich Decl."), at ¶ 6; Moses Decl., at ¶ 12.) Insulin is a hormone that facilitates the conversion and delivery of glucose — obtained from consuming food — from the bloodstream to individual cells. (Gerich Decl., at ¶ 6; Moses Decl., at ¶ 12.) If an individual lacks sufficient insulin, the level of glucose in the blood rises, and "prolonged exposure to elevated blood glucose levels can cause a wide range of very serious health complications, including foot and skin problems, nerve damage, lower extremity amputations, heart disease, blindness, kidney failure, and increased risk of early death." (Timberlake Decl., at ¶ 6.)

The "most common" forms of diabetes are type 1 and type 2 diabetes. (Gerich Decl., at ¶ 8.) "Type 1 diabetes, once known as insulin-dependent diabetes mellitus or juvenile-onset diabetes, develops when the body's immune system destroys pancreatic beta cells, the only cells in the body that produce insulin." (Id.) Approximately 5% to 10% of all diabetics have type 1 diabetes. (Id.) "Type 1 diabetes patients must take insulin and, in most cases, . . . require insulin multiple times each day." (Moses Decl., at ¶ 15.)

Type 2 diabetes, "previously called non-insulin dependent diabetes mellitus (NIDDM) or adult-onset diabetes[,] . . . typically occurs in adults over 40 years of age." (Moses Decl., at ¶ 16; see Gerich Decl., at ¶ 9 (describing type 2 diabetes).) Type 2 diabetes is "a progressive metabolic disorder due to both genetic and environmental (lifestyle) factors which reduce insulin secretion and action, impairing carbohydrate, lipid and protein metabolism and resulting in complications which reduce life expectancy and quality of life." (Gerich Decl., at ¶ 9; see Moses Decl., at ¶¶ 16-17 (explaining factors affecting type 2 diabetes).) Approximately 90% to 95% of all diabetics have type 2 diabetes. (Gerich Decl., at ¶ 10; Moses Decl., at ¶ 16.) "Many people with Type 2 diabetes can control their blood glucose by following a healthy meal plan and exercise program, losing excess weight, and taking oral antidiabetic medication. Others, however, require some form of insulin therapy." (Moses Decl., at ¶ 18; see Gerich Decl., at ¶ 10 (discussing methods of glycemic control for type 2 diabetics).)

II. Insulin Therapies for Treating Diabetes

A. Generally

There are three main types of insulin: "rapid (or short acting, mealtime, or bolus), intermediate-acting, and long-acting." (Gerich Decl., at ¶ 15.) Despite the variety of insulin types, "[b]ecause patients with diabetes each have different responses to and needs for insulin, there is no one type or even combination of insulin types that works best for everyone. [Instead,] [i]nsulin therapy must be individualized to achieve appropriate goals of glucose control for each patient." (Moses Decl., at ¶ 21.)

Types of insulin treatment currently manufactured are "characterized generally by how soon the insulin starts working or acting in the body, when it reaches maximum activity, and how long its action lasts in the body." (Moses Decl., at ¶ 19; Gerich Decl., at ¶¶ 15-16.) These key parameters for characterizing insulin are "commonly referred" to as "onset of action," "peak of action," and "duration of action." (Moses Decl., at ¶ 20; Gerich Decl., at ¶ 16.)

The "onset of action" is "the length of time after injection until insulin reaches the bloodstream and begins lowering blood glucose." (Moses Decl., at ¶ 20; see Gerich Decl., at ¶ 17 (stating same).) An insulin's "peak of action" is "the time during which insulin is at maximum strength in terms of lowering blood glucose." (Moses Decl., at ¶ 20; see Gerich Decl., at ¶ 17 (describing insulin's peak of action).) Finally, an insulin's "duration of action" is "how long [the] insulin continues to lower blood glucose," and may be dependent on the dosing, i.e., "the number/interval of administrations of the [insulin] and the amount of the [insulin] needed to achieve the desired `duration of action.'" (Moses Decl., at ¶¶ 20-21; Gerich Decl., at ¶ 17.) For instance, long-acting insulins or "basal insulins" "have a long duration of action (i.e., they attempt to replace the background insulin and thereby regulate glucose levels during the day and through the night)." (Gerich Decl., at ¶ 15.)

B. Types of Basal Insulin

1. Neutral Protamine Hagedorn (NPH)

Neutral Protamine Hagedorn ("NPH insulin") "is an insulin formulation with an intermediate duration of action of up to 16 hours." (Id. at ¶ 20; Moses Decl., at ¶ 24.) Although NPH insulin was the "standard basal insulin treatment" for many years, it has significant limitations, including, inter alia, "a pronounced peak of action . . . between four and twelve hours after injection." (Gerich Decl., at ¶ 20 Ex. E, Heise et al., Lower Within-Subject Variability of Insulin Detemir in Comparison to NPH Insulin and Insulin Glargine in People with Type 1 Diabetes, 53 Diabetes 1614-20 (2004) ("Heise Study"); Moses Decl., at ¶ 25.)

2. Lantus

Lantus is a sterile solution of insulin glargine — a recombinant human insulin analog — "that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent." (Timberlake Decl., at Ex. C, United States Food and Drug Administration ("FDA") — approved package insert for Lantus ("Lantus PI").) Lantus provides "a once-daily treatment for adults with type 2 diabetes who require basal insulin to control hyperglycemia and for adults and children (6 years or older) with type 1 diabetes." (Id. at ¶ 13; see Lantus PI.) Lantus has "up to 24 hours" duration of action. (Id. at ¶ 15.) Lantus is long-lasting because "after one injection of Lantus, insulin [glargine] is [slowly] released and absorbed into a patient's bloodstream at a relatively constant rate over a 24-hour period." (Gerich Decl., at ¶ 23.) Also, "[i]n contrast to NPH, Lantus has a slower onset and more prolonged time-action profile that has no pronounced peak of action." (Id. at ¶ 24; Lantus PI.) The Lantus PI further indicates that, in a study of patients with type 1 diabetes, "the median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH . . ., and 24 hours (range: 10.8 to 24.0 hours) for [Lantus]." (Lantus PI.)

The FDA approved Lantus in April 2000, and Sanofi launched Lantus in (1) Germany in June 2000, and (2) the United States in May 2001. (Timberlake Decl., at ¶¶ 13-14.) Sanofi markets Lantus through, inter alia, (1) meetings between Sanofi sales representatives and health care providers, (2) advertisements in trade and consumer publications, and (3) promotional materials displayed at conventions, association meetings, and health fairs. (Id. at ¶ 19.) Sanofi generated worldwide sales of Lantus in 2005 totaling approximately $1.5 billion. (Id. at ¶ 14.)

3. Levemir

Levemir is a long-acting basal insulin analog. (Moses Decl., at ¶ 34.) The FDA approved Levemir in June 2005 for "once — or twice-daily subcutaneous administration for the treatment of adults and children with Type 1 diabetes and patients with Type 2 diabetes who require basal insulin." (Moses Decl., at ¶ 36 Ex. B, FDA-approved package insert for Levemir ("Levemir PI"); Blakey Decl., at ¶ 10 Ex. A.) Similar to Lantus, the FDA approved Levemir as having "up to 24 hours" duration of action. (Levemir PI; Timberlake Decl., at ¶ 23.) The FDA also approved the "labeling" for Levemir, which includes (1) the Levemir PI, (2) the label that appears on the product itself, and (3) the label that appears on the box holding the product. (Blakey Decl., at ¶ 14.)

The Levemir PI provides, inter alia:²

• The mean duration of action of [Levemir] ranged from 5.7 hours at the lowest dose to 23.2 hours at the highest dose (sampling period 24 hours).

• In a glucose clamp study, the overall glucodynamic effect . . . of four separate subcutaneous injections in the thigh was . . . 29% in the Levemir group and . . . 40% for NPH. The clinical significance of this difference has not been established.

• After subcutaneous injection of [Levemir] in healthy subjects and in patients with diabetes, [Levemir] serum concentrations indicated a slower, more prolonged absorption over hours in comparison to NPH.

• The efficacy and safety of Levemir given once-daily at bedtime or twice-daily (before breakfast and bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH human insulin or once-daily [Lantus] in non-blinded, randomized, parallel studies of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In general, patients treated with Levemir achieved levels of glycemic control similar to those treated with NPH human insulin or [Lantus], as measured by glycosylated hemoglobin.

• Overall glycemic control achieved with Levemir was compared to that achieved with [Lantus] in a randomized, non-blinded, clinical study . . . in which patients with type 1 diabetes were treated for 26 weeks with either twice-daily (morning and bedtime) Levemir or once-daily (bedtime) [Lantus]. Insulin aspart was administered before each meal. Levemir-treated patients had a decrease in [glycosylated hemoglobin] similar to that of [Lantus].

• In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, Levemir was associated with somewhat less weight gain than NPH. . . . Whether these observed differences represent true differences in the effects of Levemir and NPH insulin is not known, [and] [t]he clinical significance of the observed differences has not been established.

• Levemir can be administered once — or twice-daily. The dose of Levemir should be adjusted according to blood glucose measurements. The dosage of Levemir should be individualized based on the physician's advice, in accordance with the needs of the patient.

2 The Court has replaced all future references to (1) "insulin glargine" with its brand name, "Lantus", and (2) "insulin detemir" with its brand name, "Levemir".

(Id.)

III. Novo's Promotional Campaign for Levemir

A. Novo's Pre-Launch Promotional Materials

Novo submitted four "`core' promotional pieces containing all of the promotional claims that it intended to use in . . . the launch of Levemir" to the FDA's Division of Drug Marketing, Advertising and Communications ("DDMAC") on December 16, 2005. (Blakey Decl., at ¶ 27.)<sup>3</sup> However, before the DDMAC provided Novo with its review, "Novo introduced doctors and other health professional to Levemir through a pre-launch experience program called `Expanding Clinical Experience with Levemir' or `Excel.'" (Id. at ¶ 19.) As part of the Excel program, "Novo created several pieces of correspondence designed to make health care providers aware of the existence of the Excel program and its potential benefits to physicians and patients [("the Pre-Launch Materials")] (e.g., free samples of Levemir for patients and a patient results monitoring program)." (Id.)⁴ Novo "principally distributed" the Pre-Launch Materials to "doctors and other medical professionals who regularly treat patients with diabetes and write prescriptions for insulin, as well as to pharmacists." (Id. at ¶ 20.) Novo included a full copy of the Levemir PI with the Pre-Launch Materials. (Id. at ¶ 18.) Novo has discontinued dissemination of all Pre-Launch Materials and "has no present intention of distributing any of the Pre-Launch Materials hereafter." (Id. at ¶¶ 19-20.)

3 Novo did not provide the Court with copies of the proposed "core" promotional materials.

4 Novo does not state that it submitted any of the Pre-Launch Materials to the FDA or DDMAC for review before disseminating the materials.

1. The "Dear Healthcare Professional" Letters

Novo sent correspondence to "nurse practitioners, physicians assistants and medical doctors from January 27, 2006 until February 17, 2006" (the "Dear Healthcare Professional Letters"). (Blakey Decl., at ¶ 21; Timberlake Decl., at ¶ 33 Exs. K-M.) The Dear Healthcare Professional Letters include, inter alia, the following statements:

• Levemir is a 24-hour basal (long-acting) insulin with effective glycemic control and few insulin-related side effects.

• The appropriate candidates for the EXCEL program are those patients who need a 24-hour basal insulin with effective glycemic control and few insulin-related side effects.

(Timberlake Decl., at Exs. K-M.)⁵

5 Although two of the three Dear Healthcare Professional Letters — directed to nurse practitioners and physicians' assistants — are dated January 29, 2006, and one of the letters — directed to medical doctors — is dated February 17, 2006, the letters contain virtually identical language. (Timberlake Decl., at Exs. K-M.)

2. The "Dear Pharmacist" Letters

Novo distributed correspondence to pharmacists from January 30, 2006, until February 24, 2006 (the "Dear Pharmacist Letters"). (Blakey Decl., at ¶ 22; Timberlake Decl., at Ex. J.) The Dear Pharmacist Letters state, inter alia, that "[Levemir] is a 24-hour basal insulin that gives your patients effective glycemic control with few insulin-related side effects." (Timberlake Decl., at Ex. J.) ChainDrugStore.net — "a network of retail pharmacies and pharmacists" — posted the Dear Pharmacist Letter on its website on or about January 30, 2006. (Blakey Decl., at ¶ 23.) Novo asked ChainDrugStore.net to remove the copy of the Dear Pharmacist Letter from its website, and it removed the letter on March 28, 2006. (Id.)

3. The Excel Brochure

Novo distributed a brochure to doctors as part of the Excel program from January 10, 2006, until March 17, 2006 (the "Excel Brochure"). (Blakey Decl., at ¶ 24; Timberlake Decl., at Ex. R.) The Excel Brochure included, inter alia, the following statement: "Levemir is for patients who need a 24-hour basal insulin with effective glycemic control and few insulin-related side effects." (Timberlake Decl., at Ex. R.)

4. The "Successful Start Program" Brochure

Novo distributed a "Successful Start Program" brochure "intended for use by patients with diabetes," which was "actually distributed to patients through their physicians" (the "SSP Brochure"). (Blakey Decl., at ¶ 20; Timberlake Decl., at Ex. S.) The SSP Brochure included, inter alia, the following statements:

• Because [Levemir] is long-acting, it works up to 24 hours.

• Levemir can work all day.

• Levemir is a long-acting insulin. That means after it is injected, it is released up to a 24-hour period.

• Levemir can be taken once a day.

• Levemir can last up to 24 hours, depending on your dose.

(Timberlake Decl., at Ex. S.)

B. Novo's Launch Materials

DDMAC provided comments to Novo regarding the claims contained in the Levemir "core" promotional materials on February 3, 2006, and February 23, 2006. (Blakey Decl., at ¶ 27.) Novo claims that it "incorporated DDMAC's comments in the core promotional pieces." (Id.) Novo's "core" promotional pieces (the "Launch Materials") being used in the Levemir launch are the (1) "Core Visual Aid", (2) "Basal Bolus Insert", (3) "Primary Care Physician Dosing Card", and (4) "Journal Ad". (Id. at ¶ 28.) Each Launch Material includes, inter alia, at least one of the following statements:

• [Levemir] help[s] your patients get to goal with up to 24-hour control.

• Levemir is indicated for once — or twice-daily subcutaneous administration.

• Less weight gain was observed with Levemir [over NPH insulin] in 12 of 12 controlled clinical trials. . . . Whether these observed differences represent true differences in the effects of Levemir and NPH insulin is not known. . . . The clinical significance of the observed difference has not been established.

• [Levemir provides] a consistent glucose response, [and patients] [g]et a consistent insulin response, injection after injection. The clinical significance of this difference has not been established.

(Id. at ¶¶ 28-32.)

Novo also "created and/or revised [based on DDMAC's comments] other promotional pieces for the Levemir launch that are `derivative' of the core pieces." (Id. at ¶ 33.) Novo claims that "[a]ll of the claims contained in the derivative promotional pieces are consistent with the comments that Novo received from DDMAC on the core promotional pieces, as well as the [Levemir PI]." (Id.) Also, Novo asserts that none of the Launch Materials (or the derivative promotional materials) (1) "state that Levemir is a `24-hour basal insulin' or that it is a `once daily basal insulin,'" and (2) "are aimed at or distributed to patients or the general public." (Id. at ¶¶ 35-36.)

CONCLUSIONS OF LAW

Sanofi moves to preliminarily enjoin Novo "from disseminating or causing to be disseminated any false representations as to the efficacy, mechanism of action, and side effects of Levemir and Lantus." (Compl., at 25-26.) Sanofi also seeks an order directing Novo, inter alia, to (1) "take all steps necessary to secure the return and destruction of all of the false advertising," and (2) "issue corrective advertising to dispel the impact and effect of the false claims previously disseminated." (Id. at 26.) The Court finds that Sanofi has not satisfied the elements of a preliminary injunction such that its requested relief is warranted.⁶

6 To the extent that the "Conclusions of Law" portion of this memorandum opinion contains findings of fact in addition to those expressly set out under the heading "Chronology of Events-Factual Findings," they shall be deemed to be part of the findings of fact.
The "Conclusions of Law" subsections of this memorandum opinion generally do not contain citations to the evidence except after quoted language. The record citations are set forth in the "Chronology of Events-Factual Findings" section of this memorandum opinion.

The findings and conclusions set forth in this opinion are preliminary only, based upon the state of the record at this stage in the litigation. See Fed.R.Civ.P. 65(a). The parties have preserved all rights to present their disputes to a fact-finder for eventual adjudication on the merits.

I. Standard for Preliminary Injunctive Relief

Injunctive relief is an "extraordinary remedy, which should be granted only in limited circumstances." Frank's GMC Truck Ctr., Inc. v. Gen. Motors Corp., 847 F.2d 100, 102 (3d Cir. 1988) (internal citation omitted). The Court must consider whether: (1) the party seeking a preliminary injunction has shown a reasonable probability of success on the merits; (2) the party will be irreparably injured by the denial of the relief; (3) granting preliminary relief will result in even greater harm to the nonmoving party; and (4) granting the preliminary relief will be in the public interest. Allegheny Energy v. DQE, Inc., 171 F.3d 153, 158 (3d Cir. 1999) (citation omitted). "The injunction should issue only if the plaintiff produces evidence sufficient to convince the district court that all four factors favor preliminary relief." AT T Co. v. Winback Conserve Program, 42 F.3d 1421, 1427 (3d Cir. 1994) (citations omitted).

Sanofi requests that the Court, inter alia, direct Novo to (1) secure the return of all of the allegedly false advertising, (2) destroy said advertising, and (3) issue corrective advertising. As such, Sanofi is, in part, seeking a mandatory injunction. An injunction is mandatory if the injunction will either (1) "alter the status quo by commanding some positive act" or (2) provide the moving party with "substantially all the relief sought and that relief cannot be undone even if the defendant prevails at a trial on the merits." Tom Doherty Assoc. v. Saban Entm't, 60 F.3d 27, 33-34 (2d Cir. 1995).⁷ Where a plaintiff seeks a mandatory injunction rather than a prohibitory injunction, the burden of showing an entitlement to relief is greater, as mandatory injunctions are generally disfavored. See Acierno v. New Castle County, 40 F.3d 645, 653 (3d Cir. 1994) ("A party seeking a mandatory preliminary injunction that will alter the status quo bears a particularly heavy burden in demonstrating its necessity."); United States v. Spectro Foods Corp., 544 F.2d 1175, 1181 (3d Cir. 1976) (stating that court's power to issue preliminary injunction, especially mandatory injunction, should be "sparingly exercised").

7 A preliminary injunction is prohibitory if it "seeks only to maintain the status quo pending a trial on the merits." Tom Doherty, 60 F.3d at 33.

II. Sanofi's Lanham Act Claims

Sanofi alleges that Novo has disseminated and continues to disseminate literally false claims regarding Levemir in violation of Section 43 of the Lanham Act, 15 U.S.C. § 1125(a). (Compl., at 24-25.)⁸ Sanofi asserts that Novo has disseminated the following four literally false claims in its promotional campaign for Levemir: (1) the 24-hour claim, (2) the once-daily claim, (3) the predictability claim, and (4) the less weight gain claim. Sanofi contends that Novo has made these false claims through its written promotional materials and through oral statements made by Novo sales representatives. (Id. at 13-15.)

8 Sanofi alleges that Novo violated Section 43(a) of the Lanham Act and the New Jersey Law of Unfair Competition. (Compl., at 24-25.) These causes of action essentially "parallel" one another. See Castrol, Inc. v. Pennzoil Quaker State Co., 169 F.Supp.2d 332, 340 (D.N.J. 2001) ("It is undisputed that the Lanham Act parallels the [New Jersey] common law of unfair competition."); see also Am. Greetings Corp. v. Dan-Dee Imports, 807 F.2d 1136, 1141 (3d Cir. 1986) ("[F]ederal law of unfair competition under § 43(a) is not significantly different from the New Jersey [common] law of unfair competition."); Birthright v. Birthright, Inc., 827 F.Supp. 1114, 1140-41 (D.N.J. 1993) ("It is well established that the test for a common law unfair competition claim under New Jersey law is essentially the same as under the federal Lanham Act."). Nonetheless, Sanofi has not argued or briefed an unfair competition claim.

Novo argues that (1) Sanofi's arguments regarding the 24-hour and once-daily claims are moot because Novo has not used those claims in its Launch Materials, (2) none of the four challenged statements violate the Lanham Act as a matter of law because they "comport substantively" with the information contained in the Levemir PI, and (3) the challenged statements are not literally false.⁹ Further, Novo contends that (1) some of the alleged promotional materials, and (2) oral representations made by Novo sales personnel, do not constitute "commercial advertising or promotion" under the Lanham Act. The Court finds that (1) Sanofi's Lanham Act claims concerning the 24-hour and once-daily statements are not moot, and (2) Sanofi has failed to demonstrate a reasonable likelihood of success on the merits of its Lanham Act claim.

9 Novo's contention that its four challenged statements "comport substantively" with the Levemir PI is the basis for a motion to dismiss the complaint filed by Novo. In light of the status of this matter, the Court has not addressed Novo's arguments relating to this issue in this memorandum opinion.

A. Mootness

Novo contends that "[b]ecause [it] (i) stopped distributing its Pre-Launch Materials that contain the statements `24-hour basal insulin' and `once-daily basal insulin,' (ii) does not intend to distribute those Pre-Launch Materials hereafter, and (iii) does not presently intend to make the challenged statements in any promotional materials in the [United States]," Sanofi's request to enjoin Novo from distributing these statements is moot. (Def. Br., at 21.) Novo also asserts that Sanofi's request is moot because it has demonstrated that there is no "reasonable expectation" that Novo it repeat these statements. (Id.) Sanofi argues that its claims are not moot because Novo has not (1) met its "formidable burden" to show that it will cease using the allegedly false statements, or (2) retrieved the Pre-Launch Materials containing the statements. The Court finds that Sanofi's contentions regarding the 24-hour and once-daily claims are not moot.

"Although a case may become moot `if the defendant can demonstrate that there is no reasonable expectation that the wrong will be repeated, this burden is a heavy one.'" Century 21 Real Est. Corp. v. Lendingtree, Inc., 425 F.3d 211, 217 (3d Cir. 2005) (quoting United States v. W.T. Grant Co., 345 U.S. 629, 633 (1953)). A case may become moot if (1) "it can be said with assurance that there is no reasonable expectation . . . that the alleged violation will recur," and (2) "interim relief or events have completely and irrevocably eradicated the effects of the alleged violation." County of Los Angeles v. Davis, 440 U.S. 625, 631 (1979). A court will not find that "voluntary cessation of the alleged [unlawful] activities rendered the case [or particular causes of action] moot [if the defendant] would simply be free to return to [its] old ways after the threat of a lawsuit had passed." Century 21, 425 F.3d at 217 (internal quotations and citation omitted).

Novo's "voluntary cessation" of the 24-hour claim or the once-daily claim in its Launch Materials does not moot Sanofi's contentions as to those claims. Although Novo has not used the two claims in its Launch Materials and has no "present intention" to make the claims, Novo has, in effect, reserved the right to make the claims should further scientific data support the claims. Sanofi has also alleged and submitted supporting certifications that Novo sales representatives were still making these claims as part of their sales presentations. As such, Novo has failed to demonstrate that there is no reasonable expectation that the alleged violation will recur. Further, Sanofi has requested that the Court require Novo to, inter alia, retrieve all of its previously distributed Pre-Launch Materials that included the two claims. Therefore, regardless of whether Novo intends to use the claims in the future, the Court must address Sanofi's contentions regarding the alleged falsity of the two claims in determining whether Novo is required to (1) retrieve all of its previously distributed Pre-Launch Materials, and (2) issue corrective advertising. Accordingly, Novo has failed to demonstrate that its present intention to voluntarily discontinue using the 24-hour and once-daily claims in its Launch Materials completely obviates the need for injunctive relief.

B. Reasonable Probability of Success on the Merits — Sanofi's Lanham Act Claims

1. Standard — Reasonable Probability of Success on the Merits

The party seeking a preliminary injunction must demonstrate a "reasonable probability of eventual success in the litigation."Kershner v. Mazurkiewicz, 670 F.2d 440, 443 (3d Cir. 1982). In evaluating whether a moving party has satisfied this first part of the preliminary injunction standard, "[i]t is not necessary that the moving party's right to a final decision after trial be wholly without doubt; rather, the burden is on the party seeking relief to make a [p]rima facie case showing a reasonable probability that it will prevail on the merits." Oburn v. Shapp, 521 F.2d 142, 148 (3d Cir. 1975) (citations omitted).

2. Lanham Act Standards

Section 43(a)(1)(B) of the Lanham Act provides, in relevant part:

(a)(1) Any person who . . . in connection with any goods or services . . . uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any . . . false or misleading description of fact, or false or misleading representation of fact which —

* * *

(B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damages by such act.

15 U.S.C. § 1125(a). A plaintiff seeking to establish a Lanham Act claim based on a false or misleading representation of a product must show that:

(1) the defendant made false or misleading statements about the plaintiff's [or his own] product; (2) there is actual deception or a tendency to deceive a substantial portion of the intended audience; (3) the deception is material in that it is likely to influence purchasing decisions; (4) the advertised goods traveled in interstate commerce; and (5) there is a likelihood of injury to the plaintiff.

Highmark, Inc. v. UPMC Health Plan, 276 F.3d 160, 171 (3d Cir. 2001).

A Lanham Act false or misleading statement can be proven in one of two ways. The plaintiff must show that "the commercial message or statement is either (1) literally false or (2) literally true or ambiguous, but has the tendency to deceive consumers."Novartis Consumer Health v. Johnson Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 586 (3d Cir. 2002). If the plaintiff can show literal falsity, "the court may grant relief without reference to the advertisement's impact on the buying public."Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 943 (3d Cir. 1993). The Court,

in analyzing whether an advertisement or product name is literally false, . . . must determine, first, the unambiguous claims made by the advertisement . . ., and second, whether those claims are false. A literally false message may be either explicit or conveyed by necessary implication when, considering the advertisement in its entirety, the audience would recognize the claim as readily as if it had been explicitly stated.

Novartis, 290 F.3d at 586-87 (quotations and citations omitted). However, "only an unambiguous message can be literally false"; if the message is susceptible to more than one meaning, the plaintiff cannot assert literal falsity. Id. at 587 (emphasis in original).

3. Commercial Advertising or Promotion

Sanofi contends that Novo has distributed its four false claims about Levemir via the Pre-Launch Materials, including the (1) Dear Healthcare Professional Letters; (2) Dear Pharmacist Letters; (3) Excel brochure; and (4) SSP Brochure. (Compl., at ¶¶ 42, 49.) Sanofi also alleges that Novo disseminated the false claims through (1) letters responding to doctors "specifically requesting information comparing Levemir to Lantus" (the "Dear Doctor Letters"); (2) meetings Novo sponsored for physicians as part of the Excel program; (3) derivative promotional pieces for use by physicians participating in Novo's "Interface" Program (the "Interface Program"); and (4) oral statements by sales representatives. (Id. at ¶¶ 41, 43, 46-48.)

Novo does not appear to dispute that the (1) the Dear Healthcare Professional Letters, (2) Dear Pharmacist Letters, (3) Excel Brochure, and (4) SSP Brochure constitute "commercial advertising or promotion" under the Lanham Act. However, Novo contends that (1) the Dear Doctor Letters are "scientific discourse" and, as such, (a) are not regulated as promotional material by the FDA, and (b) are not "commercial advertising or promotion under the Lanham Act;" (2) the "slide deck" that Sanofi contends was presented at an Interface Program is only an "early draft" and was, in fact, never presented at an Interface Program; and (3) the alleged oral representations by Novo sales representatives are not "commercial advertising or promotion." (Def. Br., at 37 n. 13; Blakey Decl., at ¶¶ 34, 38; dkt. entry no. 16, 4-11-06 Tr., at 26, 38-43, 53-56; 4-17-06 Letter from David B. Tulchin.)

a. "Commercial Advertising or Promotion"

Section 43(a)(1)(B) applies only to misrepresentations in "commercial advertising or promotion." 15 U.S.C. § 1125(a)(1)(B). Although the Lanham Act does not define "commercial advertising or promotion," representations may constitute "commercial advertising or promotion" if they are: (1) commercial speech; (2) made by a defendant who is in commercial competition with the plaintiff; (3) for the purpose of influencing consumers to purchase the defendant's goods or services; and (4) disseminated sufficiently to the relevant purchasing public to constitute "advertising" or "promotion" within that industry. Eli Lilly Co. v. Roussel Corp., 23 F.Supp.2d 460, 480 (D.N.J. 1998) (citingGordon Breach Sci. Publishers, S.A. v. Am. Inst. of Physics, 859 F.Supp. 1521, 1536 (S.D.N.Y. 1994)); see Diamond Triumph Auto Glass v. Safelite Glass Gorp., 344 F.Supp.2d 936, 941 (M.D. Pa. 2004) (applying Gordon Breach test to determine whether representations at issue were "commercial advertising or promotion" under Lanham Act); Synegy, Inc. v. Scott-Levin, Inc., 51 F.Supp.2d 570, 576 (E.D. Pa. 1999) (same).¹⁰

10 See Procter Gamble Co. v. Haugen, 222 F.3d 1262, 1273-74 (10th Cir. 2000) (adopting Gordon Breach test for determining whether representations are "commercial advertising or promotion" under Lanham Act); Coastal Abstract Serv. v. First Am. Title Ins. Co., 173 F.3d 725, 735 (9th Cir. 1999) (same); Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th Cir. 1996) (same); see also Podiatrist Ass'n v. La Cruz Azul De P.R., 332 F.3d 6, 19 (1st Cir. 2003) (acknowledging and describing Gordon Breach test); Fashion Boutique of Short Hills v. Fendi USA, 314 F.3d 48, 56-58 (adopting first, third, and fourth elements of Gordon Breach test, but expressing "no view" on second element). But see First Health Group Corp. v. BCE Emergis Corp., 269 F.3d 800, 803 (7th Cir. 2001) (declining to adopt Gordon Breach test because "[w]e have serious doubts about the wisdom of displacing the statutory text in favor of a judicial rewrite with no roots in the language Congress enacted").

Regarding the fourth element — sufficient dissemination to the relevant purchasing public — "the required level of circulation and the relevant `consuming' or `purchasing' public addressed by the dissemination of false information will vary according to the specifics of the industry." Seven-Up, 86 F.3d at 1385 (citation omitted). Thus, "[w]here the potential purchasers in the market are relatively limited in number, even a single promotional presentation to an individual purchaser may be enough to trigger the protections of the [Lanham] Act." Id. at 1386; see, e.g.,Coastal Abstract, 173 F.3d at 735 (finding that defendant title insurance company's single oral representation to mortgage company constituted promotion under Lanham Act "because . . . there were only two or possibly three institutions involved in the [plaintiff's kind of operations, the] representation" was disseminated to a sufficient segment of the relevant purchasing public").

b. The Dear Doctor Letters

Novo distributed the Dear Doctor Letters in response to doctors "specifically request[ing] information comparing Levemir to Lantus." (Blakey Decl., at ¶ 38.) Novo alleges that the Dear Doctor Letters "discuss certain clinical studies and provide scientific information about Levemir which is scientifically relevant, but is not in the Levemir Package Insert." (Id.; Timberlake Decl., at ¶ 33 Ex. N.)¹¹ The Dear Doctor Letters include, inter alia, the following statements:

11 Sanofi included copies of two Dear Doctor Letters as Exhibit N to the Timberlake Declaration. The first Dear Doctor Letter is dated December 20, 2005, but is not addressed to a specific individual. (Timberlake Decl., at Ex. N, at 1.) The second Dear Doctor Letter is undated, but appears to be directed to a specific doctor (whose name has been redacted). (Id. at 12.) Neither party has provided the Court with any information concerning the differences or similarities in the two letters. The Court notes that the wording, information presented, and organization of the two Dear Doctor Letters are substantially similar, except that the second Dear Doctor Letter appears to be an updated or revised version of the first Dear Doctor Letter. The most significant distinction — for resolving the issues raised here — between the two letters is that Novo includes in the second Dear Doctor Letter an additional "safety and efficacy" study of Levemir and Lantus in patients with Type 1 diabetes. (See id. at 19 (describing "basal-bolus study conducted in patients with type 1 diabetes," and including table (Table 3) that, inter alia, shows respective weight change (if any) for patients on Levemir and Lantus during study).)

• Levemir and [Lantus] are long-acting basal insulin analogs, with duration of action of up to 24 hours.

• [Levemir] is a long-acting recombinant insulin analog, with duration of action of up to 24 hours.

• In a euglycemic clamp study, Levemir demonstrated less intrasubject variability in its pharmacokinetic and pharmacodynamic profiles as compared to [Lantus].

Pharmacokinetic and pharmacodynamic parameters were assessed to compare the intra-subject variability of Levemir, NPH insulin, and [Lantus] in a randomized, parallel-group, double-blind trial in 54 patients (18 in each group) with type 1 diabetes. Patients were randomized to receive single injections of either 0.4 U/kg Levemir, 0.4 U/kg NPH insulin, or 0.4 U/kg [Lantus] on four separate dosing days. . . . A 24-hour euglycemic clamp procedure was performed on each dosing day. Variability was observed by comparing the insulin-action profiles assessed by glucose infusion rates (GIR) from successive injections of the same product (Levemir, NPH-insulin, or [Lantus]) in an individual subject. . . . Decreased variability in insulin action results in more consistent time-action profile on a day-to-day basis.

Intrasubject variability . . . was significantly lower . . . for all pharmacodynamic endpoints for Levemir compared to NPH-insulin and [Lantus]. Intrasubject variability for pharmacokinetic (serum level) endpoints was also lower for Levemir compared to NPH and [Lantus]. . . . These results indicate that pharamcokinetcs and pharmacodynamics of Levemir were more reproducible compared to those of NPH insulin or [Lantus].

• In a 12-month clinical study in patients with type 2 diabetes, patients in the once-daily Levemir treatment group experienced less weight gain than patients in the [Lantus] treatment group with comparable A1C control.

(Timberlake Decl., at Ex. N.)

Novo claims that "[t]he FDA considers the `Dear Doctor' [L]etter to be scientific discourse and[,] as such, the letter fits within a `safe harbor' which exempts these types of correspondence from regulation as promotional communications." (Blakey Decl., at ¶ 38.) However, Novo has not identified any statute or cited any regulation promulgated by the FDA exempting documents such as the Dear Doctor Letter into a "safe harbor" from characterization as promotional communications. Therefore, the Court will consider whether the letter constitutes commercial advertising or promotion under the Lanham Act.

The Dear Doctor Letter appears to satisfy the first three elements of the Gordon Breach test. However, Sanofi has not demonstrated that these letters were disseminated sufficiently to the relevant purchasing public to constitute "advertising" or "promotion" within that industry. Specifically, Sanofi has failed to show that a significant number of doctors, out of the vast number of primary care physicians, endocrinologists, and other doctors treating the approximately 20 million individuals with type 1 and type 2 diabetes, requested or received the Dear Doctor Letters. As such, the Court preliminarily finds that the Dear Doctor Letters do not constitute commercial advertising or promotion under the Lanham Act. Nonetheless, for purposes of addressing the literal falsity of the claims presented in the Dear Doctor Letters, the Court will assume, arguendo, that the Dear Doctor Letters constitute commercial advertising or promotion.

c. Novo's Interface Program Materials

Novo further developed "derivative promotional pieces" for use "by physicians participating in Novo's `Interface' Program, a program where physicians representing Novo discuss the use of Levemir with their peers." (Blakey Decl., at ¶ 34; Timberlake Decl., at ¶¶ 34-35 Exs. O-Q.) These derivative promotional pieces included a (1) "slide deck" to be used at Levemir speaker training meeting (the "Slide Deck"); (2) Interface program overview (the "Overview"); and (3) synopsis booklet of Levemir in-label studies (the "Synopsis Booklet"). (Timberlake Decl., at ¶¶ 34-35 Exs. O-Q.) The Slide Deck contains, inter alia, the following statements:

• Under the topic "Consistent Blood Glucose Response" — When individual absorption profiles are considered, there are two common shortcomings. First, there is often an undesirable peak in absorption and activity. The other problem has to do with variability. A peak that is predictable and consistent in timing and amplitude would be manageable, but with human insulins, absorption is often highly variable and unpredictable from injection to injection. As a result, individual insulin levels frequently fall outside the target insulin range, posing risks for hypo — and hyperglycemia.

• Introducing Levemir[:] Once-daily Basal Insulin in the Treatment of Diabetes.

• How to use Levemir, the once-daily basal insulin.

• Levemir can be used as a once — or twice-daily subcutaneous injection.

• [Levemir's] [d]uration of action is dose dependent up to 24 hours.

• Once-daily Levemir Is Associated With Less Weight Gain [Than NPH]. . . . The clinical significance of the observed difference in weight has not been established.

• Levemir Achieved Glycemic Control Comparable to [Lantus].

• Levemir Achieved Glycemic Control With Less Weight Gain [Than Lantus]. Patients treated with Levemir gained a mean of 1.1 pounds over [a] 26-week study period, and those in the [Lantus] group experienced a mean weight increase of 2.2 pounds. . . . The clinical significance of the observed difference in weight has not been established.

• The within-subject variability was lower with Levemir than with [NPH or Lantus].

• Levemir demonstrated a more consistent blood glucose response than either NPH or [Lantus].

• [In a clinical study of patients with type 2 diabetes,] Levemir plus oral agents produced effective glycemic control with less weight gain than [patients in the NPH group].

• Levemir consistently demonstrated less weight gain [than NPH or Lantus] in type 1 [and type 2] patients.

• Levemir is safe and effective to use in type 2 patients as a once-daily add — on to therapy with oral hypoglycemic agents.

(Timberlake Decl., at Ex. O, Part I, at 10, 20; Part II, at 1, 3, 5-6, 13, 15, 17-19, 22, 28-30.)¹²

12 The Slide Deck is separated into two separate sections. The Court, for ease of reference, has identified the sections as "Part I" and "Part II".

The Synopsis Booklet was "created for educational purposes only" and "contains detailed information about five of the clinical studies cited in the approved Levemir label." (Timberlake Decl., at Ex. Q.) The Synopsis Booklet includes some charts and graphs explaining the results of the various studies. (Id.) The booklet also provides "responses to unsolicited questions" in which it lists the questions and Novo's responses. (Id.) The Synopsis Booklet contains the less weight gain claim and the predictability claim. (Id.)

Novo claims that the Slide Deck attached to Sanofi's moving papers was (1) an "early draft," and (2) "never presented at an Interface meeting." (Blakey Decl., at ¶ 34.)¹³ Sanofi asserts that the Slide Deck "was provided to [a Sanofi] sales representative by a physician who attended Novo's Interface Program in Las Vegas on February 25, 2006." (Timberlake Reply Decl., at ¶ 11.) Sanofi also states that "[a]ccording to the participant list included in the binder with the copy of the slide deck, over 100 physicians attended that specific program and were presented with those slides." (Id.)

13 Novo does not specifically discuss the Synopsis Booklet in its opposition papers.

Similar to the Dear Doctor Letters, Sanofi has not made a preliminary showing that the Slide Deck or other materials distributed at any Interface Program were sufficiently disseminated to the relevant purchasing public to constitute "commercial advertising or promotion." Although Sanofi asserts that Novo conducted program training in Florida and Las Vegas involving approximately 1,500 physicians, Sanofi has not shown that presentations at these other programs were similar to, or used, the information in the Slide Deck. Nonetheless, the Court need not resolve the factual discrepancies presented by the parties declarations about whether the Slide Deck was actually presented at an Interface program because the Court, for purposes of addressing the literal falsity claims, will assume, arguendo, that the Slide Deck and Synopsis Booklet constitute "commercial advertising or promotion."

d. Oral Statements by Novo Sales Representatives

Sanofi claims that it has compiled results from marketing studies commissioned in the ordinary course of business, which show that "Novo sales representatives are communicating to physicians that Levemir is a new 24-hour, once-daily basal insulin that is predictable and will cause less weight gain than other insulins on the market, including Lantus." (Timberlake Decl., at ¶ 32.) Specifically, Sanofi conducted a physician recall study in February 2006, which "demonstrated that 83% of physicians who recalled being `detailed' about Levemir by a Novo sales representative reported that the Novo representative made comparative statements about Levemir versus Lantus." (Timberlake Reply Decl., at ¶ 4.)

Sanofi also attached to its reply brief declarations from (1) Jay Nakumara ("Nakumara"), (2) Joseph Hatfield ("Hatfield"), and (3) Daren Holaday ("Holaday"). Nakumara, the district sales manager for Sanofi's San Francisco/Hawaii region, attested that he attended the "California chapter of the American Association of Clinical Endocrinologists ("AACE") convention at the Grand Hyatt Hotel in San Francisco, attended by at least 70 physicians, nurses, and diabetes educators." (Nakumara Decl., at ¶ 3.) At the convention, Nakumara worked at the Sanofi display table and overheard Novo sales representatives — who were at a table a few feet away — make all four challenged claims. (Id. at ¶¶ 4-6.) Hatfield, a Sanofi sales representative in Michigan, stated that he had lunch with (1) a doctor during which the doctor told him that a Novo sales representative had made the once-daily, less weight gain, and predictability claims, and (2) a nurse practitioner during which the nurse practitioner told him that "she . . . heard that `Lantus has new competition' [and] `that it causes less weight gain than Lantus [and] is more reproducible than Lantus.'" (Hatfield Decl., at ¶¶ 1, 4-5.) Further, Holaday, a Sanofi hospital representative, states that he attended the Take Care of Your Diabetes convention at the Little Rock Convention Center in Little Rock, Arkansas on March 25, 2006. (Holaday Decl., at ¶¶ 1, 3.) Holaday states that Novo had a display table at the conference and that he "overheard a Novo sales representative tell a patient that Levemir `is just like Lantus' because `it is once a day and long acting.'" (Id. at ¶ 4.)

Novo contends that the Nakumara, Hatfield, and Holaday declarations "containing rank hearsay about alleged statements from a handful of Novo salespeople (some of whom are not even identified by name) are [in]sufficient to justify an injunction." (4-17-06 Letter from David B. Tulchin.) As such, Novo argues that such oral statements are not commercial advertising or promotion under the Lanham Act.

Although Novo contends that the oral statements in the above declarations are "rank hearsay," the Court is not prohibited from considering hearsay statements on a motion for preliminary injunctive relief. See Kos Pharms. v. Andrx Corp., 369 F.3d 700, 718-20 (3d Cir. 2004) (explaining that certification with "multiple levels of hearsay and . . . not based solely on personal knowledge" is potentially adequate basis for injunctive relief); see also Univ. of Tex. v. Camenisch, 451 U.S. 390, 395 (1981) ("[A] preliminary injunction is customarily granted on the basis of procedures that are less formal and evidence that is less complete than in a trial on the merits.") Also, although two of the declarations do not indicate the name of the Novo sales representative allegedly making the statement, this omission does not affect their admissibility. See Callahan v. A.E.V., Inc., 182 F.3d 237, 252 n. 11 (3d Cir. 1999) ("In a practical sense, the . . . identities [of the customers who made the statements at issue] are not important. The relevance of their statements depends only on the fact that they were the plaintiffs' customers.").

Courts have found that oral statements by sales representatives can constitute commercial advertising or promotion. See, e.g.,Enesco Group v. Jim Shore Designs, No. 05-4371, 2005 WL 3334436, at *4 (N.D. Ill. Dec. 6, 2005) (finding statements made to customers at trade shows "would logically constitute `commercial advertising' under the Lanham Act"); Zeneca, Inc. v. Eli Lilly Co., No. 99-1452, 1999 WL 509471, at *31 (S.D.N.Y. July 19, 1999) ("Courts have consistently held that oral statements by a company's sales representative concerning a product constitute `commercial advertising or promotion' under the Lanham Act.") However, the oral statements must still be sufficiently disseminated to the relevant purchasing public to constitute "commercial advertising or promotion."¹⁴ Here, Novo's declarations included accounts of allegedly false statements made by Novo's sales representatives.

14 See, e.g., Fashion Boutique, 314 F.3d at 58 (finding that 27 documented oral statements did not constitute advertising or promotion under Lanham Act); Eli Lilly, 1999 WL 509471, at *27-*44, *90-*91 (finding that numerous business records, scripts used by sales representatives, and defendant's own marketing studies, demonstrated that Eli Lilly's sales representatives were making allegedly false claims in a "systematic" and uniform way);Pfizer, Inc. v. Miles, Inc., 868 F.Supp. 437, 449 (D. Conn. 1994) (concluding that 25 affidavits submitted by plaintiff — containing hearsay accounts of allegedly false statements by defendant's sales representatives — were "not sufficiently reliable to provide the basis for a finding that literally false statements were made by defendant's representatives").

The Nakumara declaration recites statements made by Novo sales representatives at a trade show, which could constitute advertising or promotion. See Enesco, 2005 WL 3334436, at *4 (finding statements made at trade show constituted "commercial advertising or promotion"). Also, although Sanofi conducted a physician recall study indicating that 83% of physicians who recalled being "detailed" said that they heard Novo sales representatives making comparative statements — allegedly including the four challenged claims — about Levemir and Lantus, Sanofi has not provided the Court with a copy of the recall study or any indication as to the number of physicians who heard these statements. Regardless of whether Novo sales representatives have disseminated the allegedly false statements sufficiently to constitute commercial advertising or promotion, the Court will assume, arguendo, that said statements are commercial advertising or promotion in analyzing the literal falsity of the four challenged statements.

4. Whether the Challenged Statements are Literally False

a. The 24-hour claim

Sanofi argues that Novo's 24-hour claim falsely represents that Levemir "is effective — that is, . . . controls glycemic levels — for 24 hours." (Pl. Br., at 16.)¹⁵ Sanofi points out that the Levemir labeling indicates that Levemir's mean duration of action ranges from 5.7 hours to 23.2 hours. (Id.) Sanofi attaches to its moving papers a declaration of John E. Gerich, M.D., attesting that a "clinical study has shown that the average 0.4U/kg dose of Levemir yields a duration of action of under 20 hours." (Gerich Decl., at ¶ 38 Ex. H, Plank J. et al., A Double-Blind, Randomized, Dose-Response Study Investigating the Pharmacodynamic and Pharmacokinetic Properties of the Long-Acting Insulin Analog Detemir, 28 Diabetes Care 1107-12 (2005) (the "Plank Study").) Sanofi further claims that (1) "at no dose does Levemir actually last a full 24 hours," and (2) the FDA-approved labeling of "up to" 24 hours is not the same as Novo asserting that Levemir's duration of action "is" 24 hours. (Pl. Br., at 16; Pl. Reply Br., at 8-9.)

15 Novo makes the 24-hour claim in the (1) Dear Healthcare Professional Letters, (2) Dear Pharmacist Letters, and (3) Excel Brochure.

Novo contends that the Pre-Launch Materials "state correctly that Levemir is a `24-hour basal insulin.'" (Def. Br., at 26.) Novo attaches to its moving papers a declaration of Alan C. Moses, M.D., asserting that the Plank Study — relied upon by Dr. Gerich — actually "confirms that Levemir's duration of action often exceeds 24 hours, [and] explains why certain studies of insulin analogs having durations of action up to 24 hours or more can produce results indicating average durations less than 24 hours." (Moses Decl., at ¶ 41 (emphasis in original).) Dr. Moses notes that the Plank Study, similar to other 24-hour insulin studies, lasted only 24 hours, and that "even at the dosage singled-out by Dr. Gerich [(0.4U/kg)], 41.7% of patients continued to experience pharmacodynamic effectiveness at termination — i.e., in excess of 24 hours. At all higher dosages, 90.9% of patients continued to experience pharmacodynamic effectiveness after 24 hours." (Id. at ¶¶ 42-43.) Dr. Moses further explained that the author of the Plank Study stated that "`at the higher doses of [Levemir] in particular, the duration of action is underestimated because the clamp was terminated after 24 h[ours].'" (Id. at ¶ 43 (quoting Plank Study, at 1110).)

Dr. Moses also claims that Dr. Gerich incorrectly compares the median "effectiveness" of Lantus to the mean duration of action of Levemir. (See id. at ¶ 48 ("The median of a data set is not comparable to its arithmetic mean.").) Dr. Moses states that, "adopting the Lantus vernacular," Levemir would have a median effectiveness — for a 0.4 U/kg dosage — of 22.7 hours and a range between 13.8 to more than 24 hours. (Id.) Further, "[a]t a dosage of 0.8 U/kg — which is not atypical for a Type 2 diabetes patient — the median `effectiveness' would be 24 hours, with a range of between 21.0 hours and more than 24 hours." (Id.) Dr. Moses points out that studies measuring the duration of action of Lantus have concluded that Lantus has a duration of action of less than 24 hours. (Id. at ¶ 49 Ex. E (citing Lepore et al., Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of Long-Acting Human Insulin Analog Glargine, NPH Insulin, and Ultralente Human Insulin and Continuous Subcutaneous Infusion of Insulin Lispro, 49 Diabetes 2142, 2418 (2000); Gerich Decl., at Ex. E, Heise Study; Gerich Decl., at Ex. K, Fanellie et al., Pharmacodynamics of Subcutaneous Injection of Insulin Glargine After the First as Compared to Seventh Day of its Once Daily Administration in Patients with T1 DM (abstract).)

The Court must determine "first, the unambiguous claims made by the advertisement . . ., and second, whether those claims are false." Novartis, 290 F.3d at 586. The Court, when considering a claim of literal falsity, "must analyze the message in full context." Castrol, 987 F.2d at 946. The Court finds that Novo's statements in the (1) Dear Healthcare Professional Letters, (2) Dear Pharmacist Letters, (3) Excel Brochure, and (4) alleged oral representations by Novo sales representatives, that Levemir is a 24-hour basal insulin is unambiguous. The statement conveys the message that Levemir can provide effective glycemic control for 24 hours.

The Court further finds that the 24-hour claim is not literally false. The Court, in finding that the 24-hour claim is not literally false, has afforded significant consideration to the context within which the claim has been made. Sanofi has not alleged that Novo provided any promotional materials or made any oral representations containing the 24-hour claim to any individuals other than to a sophisticated audience of doctors, pharmacists, and other healthcare professionals. Also, Novo provided a copy of the Levemir PI with all of the promotional materials containing the 24-hour claim.

Although Sanofi claims that at no dose does Levemir actually last 24 hours, the Plank Study indicates that Levemir provides glycemic control for 24 hours in approximately 90% of patients at the 0.8U/kg 1.6 U/kg dosages. Although Dr. Gerich opines that the average dose of a basal insulin is 0.4U/kg, Dr. Moses states that the 0.8U/kg dose is not "atypical" for Type 2 diabetes patients. Also, at 0.4U/kg, the Plank Study shows that Levemir achieves at least 24 hours glycemic control in approximately 41% of patients.

The Court also finds that Dr. Gerich improperly opines on the 24-hour claim by comparing the median duration of action, as indicated on the Lantus PI, with the mean duration of action, as indicated on the Levemir PI. As Dr. Moses points about, applying Sanofi's "venacular", Levemir would have a median effectiveness — for a 0.4 U/kg dosage — of 22.7 hours and a range between 13.8 to 24 hours.) Further, "[a]t a dosage of 0.8 U/kg — which is not atypical for a Type 2 diabetes patient — the median `effectiveness' would be 24 hours, with a range of between 21.0 hours and more than 24 hours." (Moses Decl., at ¶ 48.)

The Court also finds Sanofi's attempt to distinguish the terms "up to" and "is" to be unpersuasive. Applying Sanofi's mechanical application of dictionary definitions (without consideration of its context) to its own product, Lantus, Sanofi would be unable to state that Lantus is a 24-hour basal insulin. The Lantus PI states that Lantus is "long-acting (up to 24-hour duration of action)." (Timberlake Decl., at Ex. C.) Also, although the Lantus PI indicates that the median duration of action was 24 hours, Dr. Gerich states that "in [his] clinical experience, one daily shot of Lantus is sufficient to control blood levels in 90-95% of patients." (Gerich Decl., at ¶ 24.) Thus, 5-10% of patients need more than one daily shot to achieve glycemic control.

Sanofi's reliance on Johnson Johnson-Merck Consumer Pharmaceuticals Co. v. Procter Gamble Co., 285 F.Supp.2d 389 (S.D.N.Y. 2003) ("JJMCP"), in support of its claim of literal falsity is misplaced. In JJMCP, the court concluded that the "advertisements at issue . . . are literally false and certainly convey a false message by necessary implication insofar as they suggest that one pill of Prilosec OTC can provide heartburn relief for 24 hours." Id. at 391. The court found that "the message created by [Procter Gamble Company's ("P G")] advertisements is that a person taking Prilosec OTC can obtain 24 hour heartburn relief with one pill." Id. at 392. The court found that one pill of Prilosec OTC did not provide any "actual relief for a period of up to four or five hours from the time it is ingested," and that P G's statement of "`One pill. 24 Hours. Zero Heartburn' simply [did] not equal `One pill. Wait 5 hours. Only then Zero Heartburn for the next 24 hours.'" Id. at 391. Thus, the Court concluded that P G "falsely claim[ed] that Prilosec OTC provides actual relief for the full 24 hour period which, of course, includes the initial five hours." Id.

Unlike the facts presented here, P G provided no evidence that Prilosec OTC actually provided heartburn relief for a 24-hour period. As discussed above, Novo has shown that Levemir can provide glycemic control for 24 hours. Further, in JJMCP, P G claimed that one pill of Prilosec OTC would provide 24 hour relief. Dr. Gerich and Dr. Moses indicate that an effective and appropriate dosage of basal insulin must be individualized to meet a particular patient's needs. The Levemir PI and Lantus PI indicate that at some dosages, these insulins do not always provide 24 hour relief. Accordingly, the Court finds that Sanofi has failed to show a reasonable likelihood of success that the 24-hour claim is literally false.

b. The Once-Daily Claim

Sanofi alleges that Novo's once-daily claim falsely characterizes Levemir as a once-daily insulin therapy. (Pl. Br., at 17.) Specifically, Sanofi asserts that "[t]his claim explicitly and unambiguously communicates the false message that Levemir need only be injected once daily in order to effectively control glucose levels in all patients." (Id.) Sanofi further claims that Novo improperly omits from the Pre-Launch Materials and other advertisements or promotional materials that Levemir must be taken "once or twice daily, rather than once daily as is Lantus." (Id.) Therefore, Sanofi argues that "Novo's omission of the fact that many patients must actually inject Levemir twice daily effectively renders Novo's statements false." (Id. at 18.)

Dr. Gerich also opines that Levemir "has not been shown to be effective with once-daily dosing compared to effective once-daily dosing insulins such as Lantus." (Gerich Decl., at ¶ 40.) He also states that "[s]tudies suggest that Levemir dosed once daily may not provide comparable glucose control to either NPH or Lantus, thus requiring consideration of twice-daily injections of Levemir in a large percentage of patients." (See id. at ¶ 41 Ex. I, Russell-Jones D. et al., Effects of QD Insulin Detemir or Neutral Protamine Hagedorn on Blood Glucose Control in Patients with Type 1 Diabetes Mellitus Using a Basal-Bolus Regimen, 26 Clinical Therapeutics 724-36 (2004); Ex. D, FDA Med. Revs. for Application Number 21-536, at 45 (Study 1337); Ex. J, Raslová K. et al., Insulin Detemir and Insulin Aspart: A Promising Basal-Bolus Regiment for Type 2 Diabetes, 66 Diabetes Res. and Clinical Prac. 192-202 (2004).)

Novo contends that its once-daily claim is not literally false because the FDA approved Levemir for once — or twice-daily administration, "there is nothing false about stating that it may be administered `once daily.'" (Def. Br., at 28.) Novo also asserts that Sanofi incorrectly focuses on the allegedly "overwhelming majority" of Novo's clinical trials which used twice-daily treatment regimes because "the supposed scarcity of testing does not make out a claim of literal falsity." (Id. at 29.) Novo argues that the Levemir PI states that Levemir is "expressly indicated for once-daily administration for any `insulin-naïve patients [patients not previously on insulin therapy] with type 2 diabetes who are inadequately controlled on oral antibiotic drugs and for `patients with type 1 or type 2 diabetes on [once-daily] basal-bolus treatment.'" (Id.) Novo asserts that Sanofi's literal falsity claim fails because it has offered no independent evidence that the once-daily claim is literally false. (Id.)

Dr. Moses cites to an abstract from a "large observational study" — the results of which will allegedly be published in June 2006 — indicating that "[o]ver a three month period, about 75% of Type 2 patients and 29% of Type 1 diabetes patients were using Levemir once daily with excellent glucose control." (See Moses Decl., at ¶ 52 Ex. G, Luddeke et al., An Evaluation of Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: German Cohort Data from the PREDICTIVE Study (abstract); see id. at ¶ 52 (citing Heise Study for proposition that "the duration of action of [Levemir] and [Lantus] may be sufficient for once-daily use in a substantial number of patients.").) Dr. Moses explains that for all insulins, "the duration of action — and, therefore, the suitability for once — or twice-daily application — depends upon the patients' insulin needs, dosage amounts, ancillary insulin and/or diabetes medications, and a variety of other clinical and physiological factors." (Id. at ¶ 53.) Dr. Moses further asserts that the flexibility that doctors have in prescribing Levemir for once — or twice-daily use, "does not preclude [using] Levemir once daily." (Id. at ¶ 56.)

The only alleged set of promotional materials containing the once-daily claim is the Slide Deck. None of the Pre-Launch or other allegedly promotional materials included the once-daily claim. Sanofi has also asserted that Novo sales representatives have made the once-daily claim to physicians and other healthcare professionals at trade shows and in sales visits. (Nakumara Decl.; Holaday Decl.; Hatfield Decl.)¹⁶ The Court finds that Novo makes the unambiguous claim that Levemir can be taken once daily.

16 The Holaday Declaration states that a Novo sales representative made the once-daily claim to a patient at a trade convention. Sanofi has presented no other documents or evidence that Novo widely disseminated any of the four challenged claims, including the once-daily claim, directly to patients. Therefore, the Court has not relied on the Holaday Declaration in analyzing Sanofi's claims.

The Court finds that the once-daily claim is not literally false. As with the 24-hour claim, the Court has afforded significant consideration to the context within which the once-daily claim has been made. Sanofi has only alleged that Novo presented the Slide Deck to doctors — a sophisticated audience — as part of the Interface Program. Although the Slide Deck does contain the once-daily claim, i.e., "Levemir, the once-daily basal insulin," the claim is followed within a couple of slides by a slide stating that Levemir is indicated — per the Levemir PI — for once — or twice-daily subcutaneous administration. (Timberlake Decl., at Ex. O, Part II, at 1-5.) Thus, the Court finds that Novo does not, as Sanofi contends, communicate in the Slide Deck that "Levemir need only be injected once daily in order to effectively control glucose levels in all patients." Novo explicitly includes (and does not exclude), as part of the presentation, the fact that Levemir can be taken once — or twice-daily. The context of the Slide Show demonstrates that Novo is providing the potential indications for Levemir, but highlighting the fact that Levemir can be administered once daily.

Regarding the alleged oral statements, Sanofi claims that Novo sales representatives made the once-daily claim at a trade show and in their "detailing" with doctors and other healthcare professionals. Sanofi has not included any materials indicating that Novo's sales representatives are informing doctors that Levemir is only a once-daily insulin, or that Levemir taken once-daily is effective for all patients. Sanofi has not demonstrated that Levemir cannot be effective if used once-daily for diabetes patients. Furthermore, although Lantus is indicated for once-daily use, Dr. Gerich has noted that 5-10% of patients need more than one injection of Lantus per day for effective glucose control. Despite the fact that Lantus is not effective if used only once daily for all patients, Sanofi asserts that it is a once-daily long-acting basal insulin. Accordingly, the Court finds that Sanofi has failed to demonstrate that Novo's once-daily claim is literally false.

c. The Predictability Claim

Novo includes the predictability claim in the Dear Doctor Letter, the Slide Deck, and the Synopsis Booklet. Sanofi also claims that Novo sales representatives made claims concerning "predictability" to physicians and other healthcare professionals. The predictability claim in the alleged promotional materials is presented virtually identically. Sanofi expressly admits that Novo is claiming, at least in its promotional materials, that predictability means "less intrasubject variability."

Sanofi claims that Novo's definition of "predictability" is not the "standard measure of predictability" or clinically relevant. Sanofi asserts that Novo's predictability claim falsely "impl[ies] that there is some clinical relevance to Levemir's decreased intrasubject variability." (Pl. Br., at 18.) Sanofi argues that the "clinically relevant attribute for a long-acting basal insulin is that it delivers a consistent level of insulin so that the blood-insulin concentration remains constant or stable over time." (Id.; see Gerich Decl., at ¶¶ 45-46 (indicating that clinically relevant comparison would compare plasma insulin levels throughout the day after these levels reached steady states).) Also, Sanofi contends that the "euglycemic clamp study" that Novo relies on in support of this claim is unreliable because it examined glucose infusion rates after a single injection. (Pl. Br., at 19-20.) Moreover, Sanofi claims that Novo's testing of intrasubject variability is irrelevant because, inter alia, the samples were taken once per day.

Novo asserts that Sanofi is attempting to interpret the term "predictability" as something different than Novo's use of the term. (Def. Br., at 30.) As such, Novo claims that "the fact that the word `predictability' is subject to differing interpretations alone sinks the claim that [its] use of the word is literally false." (Id.) Novo also notes that "Sanofi concedes that Novo's Pre-Launch Materials state expressly that `predictable' means `less intrasubject variability' in the day to day effectiveness profile of Levemir." (Id. at 31.) Thus, Novo contends that the predictability claim cannot be literally false because it stated expressly what the data portrayed. (Id.) Novo argues that Sanofi has provided no technical or clinical data indicating that "intrasubject variability" is meaningless information. (Id.) Further, the Levemir PI states that the "clinical significance of this difference has not been established." (Id. at 32.)

Dr. Moses opines that Levemir "offers the important advantage of reducing significantly the variability in glucose control from injection to injection." (Moses Decl., at ¶ 66.) Dr. Moses asserts that Dr. Gerich incorrectly contends that the "increased day-to-day predictability manifested by Levemir is irrelevant and not what clinicians generally understand by `predictability.'" (Id. at ¶ 67.) Dr. Moses notes that Dr. Gerich's own study "criticizes ultralene — a rarely used insulin — because it is `subject to much intra — and interpatient variability.'" (Id. (quoting Gerich Decl., at Ex. G, Gerich et al., Fluctuation of Serum Basal Insulin Levels Following Single and Multiple Dosing of Insulin Glargine, at 3).) Dr. Moses also cites to various other studies that have researched the intrasubject variability of Lantus. (See id. at ¶ 68 (citing studies).)

To the extent that Sanofi has asserted that Novo sales representatives have made claims about Levemir's predictability to doctors and other healthcare professionals, we conclude that Sanofi has failed to demonstrate that those claims are literally false. Throughout the written materials, Novo has not confused the term "predictable" with Sanofi's definition of predictability, i.e., a consistent daily profile without pronounced peaks and valleys. Sanofi has also not introduced any surveys or other evidence demonstrating that the audience receiving the statements has actually been misled. Therefore, Sanofi has not demonstrated that the predictability claim — as allegedly asserted by Novo sales representatives — is misleading.

Sanofi has also failed to demonstrate that "the tests relied upon by the defendant do not establish the proposition for which they are cited." Syncsort Inc. v. Sequential Software, 50 F.Supp.2d 318, 342 (D.N.J. 1999). In Novo's materials, it explains that the clinical significance of "less intrasubject variability" has yet to be established. Despite the lack of evidence of clinical significance, the FDA permitted Novo to include its predictability claim involving a comparison between Levemir and NPH in the Levemir PI. Here, Sanofi has not pointed to any test or actual flaw in the testing which refutes the predictability claim. The testing supports the proposition for which Novo makes its predictability claim, i.e., that Levemir's profile is more consistent on a day-to-day basis. Therefore, Sanofi has likewise failed to demonstrate that, with respect to testing, this claim is literally false or misleading.

d. The Less Weight Gain Claim

Sanofi asserts that Novo made the less weight gain claim in the Dear Doctor Letter, Slide Deck, and Synopsis Booklet.¹⁷ Sanofi also contends that Novo sales representatives have made this claim to physicians during sales calls and to physicians and other healthcare professionals at a trade show.

17 Sanofi attached to the Timberlake Declaration a copy of an advertisement from Novo stating (1) "[w]eight gain has long been accepted as an unavoidable consequence of most insulin therapies, including basal insulin therapy," and (2) it is developing "therapeutic solutions that will improve glucose control while helping to keep the weight off your patients' bodies." (Timberlake Decl., at Ex. H.) In Sanofi's reply brief, it argues that, because Lantus was the only long-acting basal insulin as of the date of the advertisement — January 2006 — Novo is asserting that Lantus causes weight gain. (Pl. Reply Br., at 11.) The Court notes that Sanofi did not expressly make this claim in its moving papers. However, even if Sanofi was now asserting that Novo was making such a claim, Sanofi has failed to show that the statement is literally false.

Sanofi contends that Novo's less weight gain claim is based on studies and tests that "did not establish that the amount of `less' weight gain was clinically relevant." (Pl. Br., at 21.) However, Sanofi asserts, Novo's "less weight gain claim in the `Dear Doctor' letter explicitly relies on tests or data and necessarily implies that the claim is clinically relevant." (Pl. Br., at 20.) As such, Sanofi contends that the tests referred to in the Dear Doctor Letter does not support the proposition — here, by necessary implication — that the less weight gain claim is clinically significant. (Id.) Also, Sanofi points out that the claimed difference — only one or two pounds — is, in itself, statistically insignificant. (Id.; Gerich Decl., at ¶ 49.)

Novo asserts that it has asserted truthful facts about the less weight gain data, which can never be literally false. (Def. Br., at 33.) Novo notes that Sanofi's argument, that Novo's reporting of less weight gain necessarily implies clinical relevance, is completely rebutted by Novo explicitly stating that the less weight gain data has not been shown to be clinically relevant. (Id.) Therefore, the audience of sophisticated doctors and healthcare professionals could not conclude the opposite. (Id.)

Dr. Moses defines "clinical significance" as the collateral effects — good or bad — of medical treatments, "though the collateral effects may have no proven or provable medical benefit (or detriment) in the treatment of the disease." (Moses Decl., at ¶ 76.) Dr. Moses notes that "no studies have yet to be undertaken to determine whether the incremental weight gain associated with insulin treatment (or, the lesser weight gain associated with Levemir) and the physiological consequences of weight gain is of clinical significance in the efficacy of the glucose control provided by insulin." (Id. at ¶ 78.) However, "Levemir has been clinically proven to be associated with less weight gain as compared to NPH in all 12 clinical studies of people with both Type 1 and Type 2 diabetes." (Id. at ¶ 79 (citing studies).)

Dr. Moses acknowledges that Dr. Gerich cites to a study showing that the difference in weight gain in Levemir and Lantus was not statistically significant, but notes that a second study cited in the Dear Doctor Letter showed a highly significant weight gain differential in a 12-month study comparing type 2 diabetes patients using Levemir and Lantus. (Id. at ¶ 80 Ex. V, Rosenstock et al., Insulin Detemir Added to Oral Anti-diabetic Drugs in Type 2 Diabetes Provides Glycemic Control Comparable to Insulin Glargine with Less Weight Gain (abstract).) Dr. Moses states that "[t]he consistent trend across the 12 published studies of which I am aware is that Levemir is associated with less weight gain in patients than either NPH or Lantus, and that patients switching from NPH or Lantus to Levemir typically lose weight." (Id. at ¶ 82.)

Sanofi, as a Lanham Act plaintiff, "bears the burden of showing that a challenged advertisement is false or misleading, not merely that it is unsubstantiated by acceptable tests or other proof." Sandoz Pharms. Corp. v. Richardson-Vicks, Inc. 902 F.2d 222, 228 (3d Cir. 1990) (citation omitted). In a comparison claim, such as Novo's less weight gain claim, Sanofi only need show "the tests relied upon by the defendant do not establish the proposition for which they are cited." Syncsort, 50 F.Supp.2d at 342. This, Sanofi has failed to do. The Court finds that the less weight gain claim is unambiguous. The claim provides the message that diabetes patients using Levemir gain less weight than patients using Lantus or NPH.¹⁸ The Court further finds that this claim is not literally false. Sanofi correctly notes that Novo failed to include a statement in the Dear Doctor Letter that it had not yet determined that the less weight gain claim was clinically significant. However, the Court finds that this omission does not, by necessary implication, show that the doctors reading the letter would conclude that the less weight gain claim was clinically significant. The Dear Doctor Letter did include a copy of the Levemir PI indicating that this less weight gain claim as compared to NPH was not clinically significant. Also, although Sanofi claims that no study shows that the less weight gain claim was statistically significant, Dr. Moses cites to the abstract of a study, which he claims showed a statistically significant distinction in weight gain between Levemir and Lantus. Accordingly, we conclude that Sanofi has failed to show a likelihood of success that Novo's less weight gain claim is literally false.

18 As with the predictability claim, Novo's less weight gain claim comparison with NPH is included in the Levemir PI and is not part of this motion.

III. Irreparable Injury

Sanofi claims that it will suffer indeterminable damages and lose the good will that it developed as the only long-lasting basal insulin provider in the United States if the Court does not grant injunctive relief and order corrective advertising. (Timberlake Decl., at ¶¶ 43-47.)¹⁹ Sanofi also claims that it is (and will in the future) lose market share because of the false claims. However, "a failure to show a likelihood of success . . . must necessarily result in the denial of a preliminary injunction." Morton v. Beyer, 822 F.2d 364, 371 (3d Cir. 1987). The Court, having concluded that Sanofi has not demonstrated a reasonable likelihood of success on the merits of its claims, need not determine whether Sanofi has satisfied the remaining requirements for preliminary injunctive relief. Id. Because Sanofi has failed to establish a sufficient probability of success, the denial of preliminary injunctive relief is appropriate even without specifying any findings of fact and conclusions of law as to the other factors.²⁰

19 Novo's contention that Sanofi delayed in seeking injunctive relief is unsupported by the evidence. "[D]elay is relevant in assessing irreparable harm, and that a preliminary injunction may be an inappropriate remedy where the non-movant provides proof of the movant's unexplained delay." Pharmacia Corp. v. GlaxoSmithKline Consumer Healthcare, L.P., 292 F.Supp.2d 611, 622 (D.N.J. 2003) (citations and quotations omitted). Here, however, after investigating the facts of the case, Sanofi's counsel sent a letter to Novo on February 22, 2006, allegedly complaining about Novo distributing false claims. (Timberlake Reply Decl., at ¶ 4.). Even without the letter, however, the Court finds that Sanofi did not delay in seeking injunctive relief.

20 If challenged advertising makes a misleading comparison or reference to a competitor's product by name, a court may presume irreparable harm. Novartis Consumer Health v. Johnson Johnson-Merck Consumer Pharms. Co., 129 F.Supp.2d 351, 367. "The presumption is provided because courts assume that a false direct comparison necessarily harms the goodwill of the victimized firm, and therefore constitutes irreparable harm." J M Turner, Inc. v. Applied Bolting Tech. Prods., No. 95-2179, 1996 WL 32114, at *12 (E.D. Pa. Jan. 26, 1996). Here, to the extent that the Dear Doctor Letters, Slide Deck, Synopsis Booklet, or oral representations by Novo sales representatives constitute "commercial advertising or promotion," they include comparative claims — the predictability claim and the less weight gain claim. Thus, to the extent that the law presumes irreparable harm in Lanham Act cases involving misleading comparative advertisements, Sanofi has satisfied its burden on this issue.

CONCLUSION

We conclude that Sanofi has failed to establish its entitlement to a preliminary injunction to require Novo to, inter alia, (1) take all steps necessary to secure the return and destruction of all of the allegedly false advertising, and (2) issue corrective advertising to dispel the impact and effect of the allegedly false claims previously disseminated. Specifically, Sanofi has not shown a reasonable likelihood of success on the merits that the four challenged statements are literally false under the Lanham Act. Therefore, the Court will deny the motion for a preliminary injunction in an appropriate order.